Orthopedic device for distributing pressure

ABSTRACT

The present invention alleviates pain and discomfort from a limb of a patient by redistributing pressure on the limb. The present invention involves an orthopedic device for redistribution of pressure exerted on a limb of a patient. The device comprises a pressure-absorbing member and a breakable container disposed in the pressure absorbing member. The pressure absorbing member is contoured to cooperate with the shape of the limb. The pressure absorbing member has a pressure receiving cavity formed therein. The breakable container is disposed in the pressure receiving cavity and includes a reactant molding material. The breakable container has a predetermined elastic threshold to allow the breakable container to break at a high pressure area and to allow the reactant molding material to disperse from the high pressure area upon pressure exertion on the breakable container by the limb.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application and claims the benefit ofU.S. non-provisional application Ser. No. 10/756,611, Jan. 13, 2004 andentitled “ORTHOPEDIC DEVICE FOR DISTRIBUTING PRESSURE,” the entirecontents of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

The present invention relates to an orthopedic device for redistributionof pressure exerted on a limb of a patient.

Orthopedic and podiatric devices are common and have been used for manyyears to treat patients with poor foot mechanics, insensitive foot, andfoot pain. Foot specialists, such as podiatric and orthopedic surgeons,have treated such patients by prescribing shoe inserts and foot archsupports to alleviate pressure exerted on various areas of a foot of apatient. For example, shoe inserts and foot arch supports have been usedto help patients undergoing podiatric therapy for plantar fasciitis. Inmany situations, a polyurethane foam shoe insert for cushion or supportmay alleviate a patient's foot discomfort.

However, in many other situations, a patient's discomfort may be moreserious. For example, pressure or tension on a patient's foot may bedirected on a pressure point or particular concentrated areas, includinga metatarsal head, a metatarsal base, and a calcaneal tubercle of a footof a patient. These concentrated areas may be referred to as highpressure points due to exerted pressure from weight or high stressactivities. High pressure points may cause substantial discomfort topatients, risk of ulceration of the leg or foot and accelerateddegeneration of fat pad of the foot.

Treatment for customized pressure relief on limbs, e.g. feet orprosthesis liners, is relatively time consuming and expensive.Typically, a customized shoe insert, orthotic or foot arch support iscreated by a foot specialist, orthotist or biomechanical lab. Theprocess of creating a customized shoe insert typically involves aplaster cast of the foot or leg. The foot is generally casted in a“neutral position” or a relaxed position of the forefoot, mid-foot, andrear foot. From these casts, plaster is poured therein to produce apositive mold or impression of the patient's foot. The shoe insert isthen constructed from the positive mold.

Although adequate, current ways of treating for the pressure relief ofjoints of the foot and distal leg pressure may be improved. Presentmethods correct static pressure of the foot or leg, but not dynamicpressure thereof.

Thus, there is a need for a more efficient, time saving device fortreating patients with foot pain due to poor foot mechanics, insensitivefoot and those with a decreased fat pad of the foot or leg.

BRIEF SUMMARY OF THE INVENTION

The present invention provides for an efficient, time saving device fortreating patients having foot discomforts, insensitive foot, anddecreased fat pad.

The present invention also provides for treating diabetic patients andthose with an insensitive foot or leg. Disease processes render the footand leg susceptible to additional complications due to alteredneurological, orthopedic, and vascular complications. The presentinvention provides for a dynamic molding to relieve pressure points toallow for additional comfort and decrease the risk of ulcerations.

In one aspect, the present invention provides an orthopedic device forredistributing pressure exerted on a limb of a patient. In thisembodiment, the device comprises a pressure absorbing member and abreakable container disposed in the pressure absorbing member. Thepressure absorbing member is contoured to cooperate with the shape ofthe limb. The pressure absorbing member has a pressure receiving cavityformed therein. The breakable container is disposed in the pressurereceiving cavity and includes a reactant molding material. The breakablecontainer has a predetermined elastic threshold to allow the breakablecontainer to break at a high pressure area and to allow the reactantmolding material to disperse from the high pressure area upon pressureexertion thereon by the limb.

In another aspect, the present invention provides a method ofredistributing pressure on a limb of a patient for orthopedic therapy.The method comprises providing a pressure absorbing member having apressure receiving cavity formed therein and a breakable containerdisposed in the pressure receiving cavity. In this embodiment, thebreakable container has a reactant molding material and a predeterminedelastic threshold. The method further includes receiving pressure on thebreakable container at the predetermined elastic threshold to define ahigh pressure area and dispersing the reactant molding material from thehigh pressure area. After curing, the reactant molding material forms apositive mold or impression of the patient's foot to redistribute thepressure on the limb.

Further objects, features and advantages of the invention will becomeapparent from consideration of the following description and theappended claims when taken in connection with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an orthopedic device in accordance withone embodiment of the present invention;

FIG. 2 is a cross-sectional side view of the orthopedic device takenalong line 2-2 of FIG. 1;

FIG. 3 is an exploded view of the orthopedic device of FIG. 1;

FIG. 4 is a plan view of a base layer of the orthopedic device inaccordance with one embodiment of the present invention;

FIG. 5 is a plan view of a base layer of the orthopedic device inaccordance with another embodiment of the present invention;

FIG. 6 is a cross-sectional view of an orthopedic device in accordancewith still another embodiment of the present invention;

FIG. 7 is a plan view of an orthopedic device in accordance with yetanother embodiment of the present invention;

FIG. 8 is a cross-sectional view of the orthopedic device taken alongline 8-8 of FIG. 7; and

FIG. 9 is a cross-sectional view of the orthopedic device dispersing areactant molding material.

DETAILED DESCRIPTION OF THE INVENTION

The present invention generally provides a customized orthopedic devicefor redistributing pressure exerted on a limb of a patient. In oneembodiment, the orthopedic device hypogenically takes on the contours ofthe plantar side of a patient's limb, when placed in contact therewithand when pressure is exerted thereon. While avoiding a patient'spotential allergic reaction to a molding material, the orthopedic deviceforms to the shape and contour of the patient's limb in a timely manner.

FIG. 1 illustrates a customized orthopedic device 10 in accordance withone embodiment of the present invention. As shown, the device 10comprises a pressure absorbing member 13 having a contact layer 14 and abase layer 16 adhered to the contact layer 14 at its periphery. In thisembodiment, the pressure absorbing member 13 is a shoe insert having ashape of a patient's foot to absorb pressure exerted by the foot of thepatient. However, as described in greater detail below, it is to beunderstood that the pressure absorbing member may take on any other formto accommodate any limb of a patient.

The contact layer 14 may be comprised of Plastazote™, Poron™, Neoprene™,or any other suitable material. The base layer 16 may be injectionmolded or stamped with a cupped heal, arch pad, or metatarsal pad andmay be made of any suitable material such as polyurethane. Plastazote™is a high quality, light weight, closed cell polyethylene foam that isnon-allergenic and may be used in direct contact with the skin.Plastazote™ is a heat moldable, grindable and washable material.Neoprene™ polychloroprene is a synthetic rubber. Poron™ is amicropourous polyurethane foam. The base layer and the contact layer maybe adhered together by gluing or sonic welding or by any other suitablemeans.

The pressure absorbing member 13 is contoured to cooperate with the limbof a patient. The contact layer 14 is configured to engage the limb of apatient. As shown in FIGS. 2 and 3, the base layer 16 includes an innersurface 17 having stress portions or openings 18, 19, 21 formed thereon.The contact layer 14 and the base layer 16 are aligned and cooperatewith each other to form pressure receiving cavities 20 therebetweendefined by the stress portions 18, 19, 21 of the base layer.

Device 10 further includes a breakable container 23 disposed in eachpressure receiving cavity 20. Each breakable container 23 contains areactant molding material, e.g., liquid latex or natural rubber and hasa predetermined elastic threshold to allow the breakable container 23 toopen or break at a high pressure area 30. The breaking of the breakablecontainer 23 allows the reactant molding material 26 to be dispersedfrom the high pressure area 30 upon stress on the breakable container23.

As the breakable container opens, the reactant molding material isdispersed to an area of lower pressure within the stress portion,thereby forming to the contour of the limb to form a positive mold orimpression of the patient's foot. The reactant molding material is thenallowed to cure and solidify to take on the contours of the limb. Thereactant molding material provides greater surface area contact betweenthe limb and the contact layer 14 at the high pressure area 30. As aresult, the reactant molding material provides added support to the limband redistributes pressure exerted thereon.

In this embodiment, each breakable container 23 has an elastic thresholdto rupture or break the breakable container, thereby allowing thereactant molding material to be dispersed within the pressure receivingcavities. In this embodiment, the elastic threshold is defined by arupture tension of about 15 pounds per square inch (psi). In anotherembodiment, the elastic threshold may be defined by a 10% stretchthreshold of the material of the breakable container 23.

The predetermined elastic threshold may be determined by any suitablemeans to define a threshold at which the breakable container rupturesthereby allowing the reactant molding material to be dispersed withinthe respective pressure receiving cavities. For example, rupture tension(RT) may be provided as follows:RT=force per unit length,wherein tension (T), pressure (P), and radius (r) are related byT=P×r.Using Young Modules of polyethylene as 1 megapascal and a thickness ofsheet (d) of 0.5 millimeters (mm), T and strain are related byT=modulus (e)×thickness of sheet×0.1 strain.Thus,${{{T = {Young}}’}s\quad{modules} \times \frac{d}{r} \times 0.1\quad{strain}},$to provideRupture tension (RT)=0.1 megapascal=100 kilopascal=1 ATM=≅15 psi.

FIG. 4 illustrates one embodiment of the pressure absorbing member 13 ofthe orthopedic device 10. As shown, the stress portions 18, 19, 21 areformed at a rear foot portion 34, a mid-foot portion 33, and a fore-footportion 32, respectively. As it can be seen, the rear foot portion is inalignment with the calcaneal tubercle of a patient's foot. The mid-footportion 33 is in alignment with the fifth metatarsal base of a patient'sfoot. Moreover, the fore-foot portion 32 is in alignment with the firstmetatarsal head, the second metatarsal head, the third metatarsal head,the fourth metatarsal head, and the fifth metatarsal head of a patient'sfoot.

In this embodiment, the fore-foot portion 32, the mid-foot portion 33,and the rear foot portion 34 are formed along a separate stress portionand pressure receiving cavity of the pressure absorbing member. However,it is to be understood that each stress portion may be formed in anyother suitable manner. For example, as shown in another embodimentdepicted as reference numeral 116 in FIG. 5, the fore-foot portion ofthe pressure absorbing member includes five separate stress portions 118a-118 e, one of each being in alignment with the first metatarsal head,the second metatarsal head, the third metatarsal head, the fourthmetatarsal head, and the fifth metatarsal head of a patient's foot.Thus, in this embodiment, the device 110 includes a plurality ofbreakable containers in fore-foot portions 132 a-132 e.

The breakable container may be configured to rupture at any suitablelocation thereon to allow the reactant molding material to be dispersedwithin the respective pressure receiving cavity of the device. Thebreakable container may be made of a low density polymer, e.g., lowdensity polyethylene or low density polypropylene

More specifically, as shown in FIG. 4, the base layer 16 furtherincludes stress portion 19 formed thereon and located at the mid-footportion 33. The mid-foot portion 33 may be referred to as a fifthmetatarsal base portion which, in use, is in alignment with the fifthmetatarsal base of a patient's foot. Moreover, the base layer 16 furtherincludes stress portion 21 formed thereon and located at the rear footportion 34. The rear foot portion may be referred to as a calcanealtubercle portion which, in use, is in alignment with the calcanealtubercle of a patient's foot. Breakable containers containing thereactant molding material are also disposed in the mid-foot portion andthe rear foot portion of the pressure receiving cavity of the baselayer.

FIG. 6 illustrates orthopedic device 210 having similar components asorthopedic device 10 described above. However, rather than having aperipheral shape of a foot of a patient, device 210 takes on aperipheral shape of a proximal end of a prosthesis and on a limb stump.For example, orthopedic device 210 may take on a shape to cooperate withthe proximal end of a prosthetic leg 213 of a patient, thereby engagingthe end of the prosthetic limb and receiving the limb of the patient. Asshown, device 210 may comprise a pressure absorbing member 213 having acontact layer 214 and a base layer 216 peripherally adhered to thecontact layer 214, similar to the pressure absorbing member 13, contactlayer 14, and base layer 16 of the device 10.

FIG. 6 further illustrates a plurality of breakable containers 223disposed within pressure receiving cavities 220 of the pressureabsorbing member. Device 210 may be configured to receive distal ends ofa femur stump or a tibia or fibula stump of a patient. Moreover, it isto be understood that formation of the stress portions, the pressurereceiving cavities, and the location of the high pressure areas may varyand would not fall beyond the scope or spirit of the present invention.

In use, the orthopedic device redistributes pressure on a limb of apatient for orthopedic therapy. The breakable container receivespressure from the limb of the patient. At the predetermined elasticthreshold of the breakable container, the reactant molding material isdispersed from the high pressure area to the pressure receivingcavities. After curing, the reactant molding material defines a positivemold or impression of the patient's foot to alleviate pain anddiscomfort.

FIGS. 7-9 depict another embodiment of the present invention. As shown,orthopedic device 310 includes similar components as the device 10 inFIG. 1. For example, device 310 may comprise a pressure absorbing member313 having a contact layer 314 and a base layer 316 peripherally adheredto the contact layer 314, similar to the pressure absorbing member 13,contact layer 14, and base layer 16 of the device 10. In thisembodiment, the pressure absorbing member 313 comprises a heat sensitivebreakable container 323 including the reactant molding material andhaving one-way valves 327 through which the reactant molding material326 may exit. The breakable container 323 is configured to selectivelydegrade or rupture at a predetermined temperature and at pressure pointswhere the one-way valves 327 are disposed. Preferably, the breakablecontainer 323 is disposed in stress portion 319 of pressure absorbingmember 313. As shown, stress portion 319 is formed adjacent the arch ofthe foot of a patient. Since the arch portion of the foot is arelatively low pressure area of a patient's foot, the breakablecontainer 323 will not be ruptured during normal use at temperaturesbelow the predetermined temperature.

However, when placed in a heat source, e.g., an oven, at or above thepredetermined temperature, heat sensitive breakable container 323 willselectively rupture at the pressure points at which the one-way valvesare disposed, thereby allowing the reactant molding material to exittherefrom. Pressure applied from the patient's foot then will cause thereactant molding material to disperse or flow to stress portions 318 and321 of the pressure absorbing member 313 while avoiding backflow back tostress portion 319.

As mentioned, the heat sensitive breakable container 323 is comprised ofmaterial configured to rupture or degrade at a predeterminedtemperature. The predetermined temperature may be preferably greaterthan 100° F., more preferably greater than 120° F., and most preferablygreater than 140° F. The material may be a polymeric material such aslow density polyethylene, linear-low density polyethylene,polypropylene, or any other suitable material.

The one-way valves may be constructed by any suitable means onto thebreakable containers such that the reactant molding material may bedispersed to the pressure receiving cavities.

In use, the orthopedic device depicted in FIGS. 7-9 redistributespressure on a limb of a patient for orthopedic therapy. In thisembodiment, the pressure absorbing member is heated to the predeterminedtemperature threshold defining a high temperature area of the breakablecontainer. Pressure placed on the device from the patient's limb forcesthe reactant molding material to the stress portions. After drying, thereactant molding material produces a positive mold or impression of thepatient's foot, thereby redistributing the pressure on the limb andalleviating pain on the foot.

While the present invention has been described in terms of preferredembodiments, it will be understood, of course, that the invention is notlimited thereto since modifications may be made to those skilled in theart, particularly in light of the foregoing teachings.

1-17. (canceled)
 18. An orthopedic device for redistribution of pressureexerted on a limb of a patient, the device comprising: a pressureabsorbing member contoured to cooperate with the shape of the limb, thepressure absorbing member having a plurality of pressure receivingcavities formed therein; and a breakable container disposed in one ofthe pressure receiving cavities and including a reactant moldingmaterial, the breakable container having a predetermined temperaturethreshold to allow the breakable container to break at a hightemperature area and the reactant molding material to disperse from thehigh temperature area upon heat on the breakable container beyond thepredetermined temperature threshold.
 19. The device of claim 18 whereinthe pressure receiving cavities are formed at a rear foot portion, amid-foot portion, and a forefoot portion.
 20. The device of claim 19wherein the rear foot portion is in alignment with one of the medialtubercle or lateral tubercle of the calcaneal tubercle of the patient.21. The device of claim 19 wherein the mid-foot portion is in alignmentwith the fifth metatarsal base of the patient.
 22. The device of claim19 wherein the fore-foot portion is in alignment with the firstmetatarsal head, the second metatarsal head, the third metatarsal head,the fourth metatarsal head, and the fifth metatarsal head of thepatient.
 23. The device of claim 18 wherein the breakable container ismade of a low density polymer.
 24. The device of claim 18 wherein thereactant molding material is made of latex.
 25. The device of claim 18wherein the pressure absorbing member includes: a contact layer forengaging the limb of the patient; and a base layer including an innersurface having a stress portion formed thereon, the base layer beingaligned with the top layer and cooperating therewith to form thepressure receiving cavity adjacent the stress portion.
 26. The device ofclaim 18 wherein the pressure absorbing member includes: a base layer;and a top layer for engaging the limb of the patient, the top layerincluding an inner surface having a pressure receiving portion formedthereon, the top layer being lined with the base layer and cooperatingtherewith to form the pressure receiving cavity at the pressurereceiving portion.
 27. The device of claim 18 wherein the predeterminedtemperature threshold is greater than 100° Fahrenheit.
 28. The device ofclaim 18 wherein the predetermined temperature threshold is greater than120° Fahrenheit.
 29. The device of claim 18 wherein the predeterminedtemperature threshold is greater than 140° Fahrenheit.
 30. (canceled)31. A method of redistributing pressure on a limb of a patient fororthopedic therapy, the method comprising: providing a pressureabsorbing member having a pressure receiving cavity formed therein and abreakable container disposed in the pressure receiving cavity, thebreakable container having a reactant molding material and apredetermined temperature threshold; heating the pressure absorbingmember to the predetermined temperature threshold to define a hightemperature area of the breakable container; and dispersing the reactantmolding material from the high temperature area to redistribute thepressure on the limb.